SuperBall-RC
K-Number: K244015 · 2025-02-19
ApplicantArcuro Medical , Ltd.
Decision Date2025-02-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SuperBall-RC is a medical device manufactured by Arcuro Medical , Ltd.. It received FDA 510(k) clearance on 2025-02-19 under approval number K244015. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SuperBall-RC?
SuperBall-RC is a medical device that received FDA 510(k) clearance on 2025-02-19. It is manufactured by Arcuro Medical , Ltd.. The 510(k) number is K244015.
When was SuperBall-RC approved by the FDA?
SuperBall-RC received FDA 510(k) clearance on 2025-02-19, under approval number K244015.
What company makes SuperBall-RC?
SuperBall-RC is manufactured by Arcuro Medical , Ltd..
What is the FDA product code for SuperBall-RC?
The FDA product code for SuperBall-RC is MBI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.